Baxter Healthcare, S.A.

FDA Device Registration & Listing · Haina San Cristobal, DO · Registration 9612052

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9612052
FEI Number
3002806443
Entity Name
Baxter Healthcare, S.A.
City/State/Country
Haina San Cristobal, DO
Establishment Address
Parque Industrial ITABO, Carretera Sanchez KM 18 1/2 Buildings 48, 49, and 50, Haina San Cristobal 21426, DO
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)
Owner / Operator Contact Address
One Baxter Parkway, Deerfield, IL 60015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211649
PMA Number
N/A

All Registered Proprietary Names

Bard Epidural Spike Tubing Set Continu-Flo Clearlink Interlink Control-A-Flo I.V. Administration Set with Control-A-Flo Regulator PCA Syringe Sets MICROMIX BCR COMPOUNDER All-In-One Two Chamber Container Automix 3+3/AS Compounder System REPEATER PUMP Extension Set MICROMIX COMPOUNDER AN Abacus Luer Lock Universal Spike EM2400 Pharmacy Compounder INTELLIFILL I.V. ExactaMix Pro 2400 Display Module - Refurbished ExactaMix Pro 2400 Display Module ExactaMix Pro 1200 Display Module - Refurbished ExactaMix Pro 1200 Display Module LOGIX Transfer Set REPEATER PUMP Tube Sets AUTOMIX 3+3 COMPOUNDER Duo-Vent Clearlink Interlink Solutions Administration Sets with 0.2 Micron Filter Continu-Flo Clearlink System Solution Set Solution Sets, Extension Sets Continu-Flo Duo-Vent Blood Recipient Set Clearlink System PrisMax CHEMO-AIDE DISPENSING PIN Solution Set Secondary Medication Set ContinuFlo Solution Set Control-A-Flo Duo-Vent Clearlink Continu-Flo Interlink Intravascular Administration Sets Clearlink System Solution Set Bard Epidural Spike Tubing Set Solution Administration Sets Clearlink 3 Port Adapter Solution Set for Epidural Use TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Interlink Uromatic Arthromatic Blood Administration Sets Paclitaxel Sets Interlink Continu-Flo Duo-Vent Interlink System Micro-Volume Interlink MICRO-VOLUME Extension Set Cystoscopy Irrigation Set TUR Irrigation Set Blood Recipient Set Clearlink Interlink FENWAL BLOOD RECIPIENT SET Integrated APD Set with Cassette-3 prong Interlink System T-Connector ExtSet Interlink Blood Administration Set Intravascular Extension Set (Light Resistant Extension Set) Solution Administration Set Interlink Clearlink Duo-Vent Continu-Flo Intravascular Administration Sets with Stopcock and Manifold Radiation Sterilized Extension Sets Control-A-Flo Interlink Continu-Flo Duo-Vent Buretrol Mini-Infuser Stopcock and I.V. Solution Administration Sets with Stopcocks Clearlink Continu-Flo Interlink PCEA Syringe Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-07-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-01-05
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2007-07-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-01-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-05-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-08-25
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2017-11-09
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2017-12-31
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2007-07-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-11-11
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2025-04-02
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-04-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-04-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-11-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-12-07
HRX Arthroscope Orthopedic Class 2 888.1100 2007-12-03
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-03
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2022-12-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-01-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-15
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2012-03-16
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2017-11-09
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 1997-07-10
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2011-04-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2021-06-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-07-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2023-04-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-03-07
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2013-03-07
PWH Administrations Sets With Neuraxial Connectors General Hospital Class 2 880.5440 2024-06-12

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014226707 BARDY DIAGNOSTICS, INC. Bellevue, WA, US
3019257308 VIDEOMED SRL LIMENA Padova, IT
1314492 Baxter Healthcare Corporation MEDINA, NY, US
3007143268 Baxter Medical Systems GmbH + Co. KG SAALFELD Thuringia, DE
8010130 BAXTER SA LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612052. Last updated year: 2026. Please use registration number 9612052 when referencing this establishment in official correspondence.
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